Copan Italia recalls 1ml of DTT in liquid phase

Treatment reagent functionality in respiratory specimens fluidification cannot be guaranteed.

On October 29, 2025, Copan initiated a Urgent: Medical Device Recall Notification via Email to affected consignees Copan ask consignees to take the following actions: 1. Further distribution or use of the remaining product must stop immediately: trace and dispose of all affected products. 2. This notice should be passed on to all those who need to be aware within your organization. 3. Ensure that the same obligations (communication to end users and related evaluation activities) are guaranteed by any additional Customer. In particular, if you have further distributed the devices, please provide those Customers a copy of the recall notification and response form. 4. Confirm you have read and understood the recall instructions provided in the letter, in writing. If you have any questions, call Chief Operating Officer, at 030-2687211.

• FDA enforcement recordOfficial FDA database entry for Z-0943-2026
• FDA device classification · PPMOfficial FDA classification for this device type
• CFR regulation · 21 CFR 864.4010The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Copan ItaliaSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.